A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030263

Enrollment

Registered

2009-12-11

Start date

2008-06-30

Completion date

2010-03-31

Last updated

2010-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus

Brief summary

We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.

Interventions

OTHERFluorescence-aided confocal endomicroscopy guided biopsy.

Fluorescence-aided confocal endomicroscopy guided biopsy.

OTHERRandom four-quadrant biopsies.

Random four-quadrant biopsies.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age at least 18. * Barrett's esophagus * Acid suppressive therapy * Endoscopic surveillance

Exclusion criteria

* Pregnancy or lactation * Allergy to fluorescein * Endoscopic esophagitis Los Angeles classification A to D * Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion * Obvious mass lesions or cancer

Design outcomes

Primary

Measure	Time frame
Whether specialized columnar epithelium was detected.	At biopsy on Day 0.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026